Method Lifecycle Management Blogs & Podcasts

In recent years, the increased number of method transfer failures has led to greater transfer scrutiny by industry and regulators. And for good reason. Simple paper transfers between sending and receiving units and provision of ambiguous information are widely regarded as insufficient. These outdated practices are now being superseded by more proactive approaches to support successful method transfer, including the provision of method transfer packages and improved lab-to-lab communication¹. Indeed, it was a decade ago that Nethercote, et al² described the benefits of Quality-by-Design based method development with the goal of creating more robust analytical procedures. Despite these advances, however, there are still situations where methods that come into the receiving lab are poorly understood, or insufficient information is available. Even with the implementation of pharmacopoeial methods, or well-understood robust methods, predicting problems can be challenging, and many only show up over time.

Sample handling and preparation can have a substantial effect on an analytical method’s variability and data quality.  It is important to consider and address the risks associated with sample preparation as part of the method development process.  This requires carefully designed and executed experiments and clear documentation in the method to give the analyst an effective analytical control strategy. Through proper technique, the choice of reproducible consumables and method lifecycle approaches, including an Analytical Target Profile (ATP), risk assessment (RA) and analytical control strategy (ACS), an analyst can effectively mitigate risk and improve the robustness of their analytical methods.